HIGH

BioPro Recalls Femoral Head Components Due to Sterility Risk

BioPro recalled 147 femoral head components on September 9, 2025. A packaging defect may compromise sterility, increasing infection risk. The recall affects models distributed in Texas and Michigan.

Quick Facts at a Glance

Recall Date
September 9, 2025
Hazard Level
HIGH
Brand
BioPro
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioPro, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Product Details

The recall includes BioPro Femoral Heads with part IDs 18593, 18594, 19003, 19004, 19005, 19006, 19007, 19008, 19053, 19054, 19055, 19056, 19057, 19130, 19131, 19132, 19133, 19134, and 19135. These components were distributed domestically in the United States.

The Hazard

A potential packaging issue may compromise the sterile barrier of these medical devices. Loss of sterility could lead to a serious risk of infection if the device is implanted.

Reported Incidents

As of now, no specific injuries or incidents have been reported related to this recall. However, the risk of infection poses a significant health concern.

What to Do

Patients and healthcare providers should stop using these femoral head components immediately. Contact BioPro, Inc. or your healthcare provider for further instructions.

Contact Information

For more information, visit the BioPro website or call their customer support. Detailed recall instructions can also be found through the FDA's enforcement report.

Key Facts

  • 147 units recalled
  • Affected models include 18593, 18594, and others
  • Risk of infection due to compromised sterility
  • Contact BioPro for instructions
  • Recall date: September 9, 2025

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeFemoral Head Components
Sold At
Multiple Retailers

Product Details

Brand
Model Numbers
18593
18594
19003
19004
19005
+14 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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